Diagnostic Value of Transbronchial Lung Cryobiopsy

• Conditions: Interstitial Lung Disease

• Registration Number: NCT02579304
• Lead Sponsor: KU Leuven

Brief Summary

Evaluating the diagnostic value of transbronchial lung cryobiopsy (TBLC) as well as its procedural feasibility and safety in a prospective series of 20 patients with diffuse interstitial lung diseases (DILD) who are referred for invasive histopathological diagnostics

Detailed Description

Before one is able to state that TBLC is a technique that is an alternative for VATS biopsy, the diagnostic value of TBLC should be assessed and the value of the histopathological sampling should be compared with what is achieved by surgical lung biopsy. For this purpose direct comparison between VATS biopsy and TBLC is unavoidable. By including TBLC in the work-up of patients with DILD in which histopathological assessment is indicated (as proposed by MDD), we want to assess 3 major points of concern.

Agreement for the histopathological diagnosis between VATS biopsy and TBLC. Value of TBLC in the specific diagnosis in ILD.

Study Timeline

• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-24
• Study Start: 2019-01
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• • Case of DILD presented at the MDD
• Referral for VATS biopsy as advised by MDD.
• Informed consent available
• Age > 18
• FVC > 50%pred
• DLCO > 40%pred
• PaO2 > 65 mmHg, pCO2 < 45 mmHg
• No exclusion criteria

Exclusion Criteria

• • Age > 75
• PAPS >40mmHg as measured on transthoracic cardiac ultrasound
• Platelet count <100000/µl
• INR > 1.4
• BMI >30
• Diffuse bullous lung disease
• Active anti-platelet or anticoagulant treatment
• Active heart failure or unstable coronary heart disease
• Patients unfit for VATS under general anaesthesia as assessed by the surgeon and/or anesthesiologist

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
histopathological agreement	2 years	Histopathological diagnostic intra-observer agreement between Video-assisted thoracosopic surgery biopsy and TBLC (kappa value)

Secondary Outcome Measures

Name	Time	Method
procedural safety : bleeding	periprocedural 1 hour	incidence of bleeding (number of case)
procedural safety : penumothorax	periprocedural 1 hour	pneumothorax rate (number of cases)
procedural safety : bleeding (2)	periprocedural 1 hour	severity of bleeding (grade 1-2-3)
procedural safety : bleeding (3)	periprocedural 1 hour	duration of bleeding (seconds)

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium